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Validation Consultant (C&Q)

Raleigh-Durham, NC
Validation Consultants (C&Q)
PharmEng Technology is currently seeking multiple Validation Consultants for projects across the US. The position is available immediately conditional of a successful interview.

Job Description:
  • Provide direct execution support for C&Q activities.
  • Author and execute qualification documents such as Validation Plans, Risk Assessments, Qualification Plans, Installation Qualification Protocols, Installation Qualification Protocols, Operations Qualification Protocols, Qualification Summary Reports, Trace Matrices, URS and Specifications.
  • Verification protocols will be written and tested so as to enforce user & equipment safety at all times.
  • Verification IOV and PQ testing must be cGMP compliant. The ultimate goal of Verification is to verify end product conformance to regulatory requirements and critical aspects.
  • Develop Final Reports of all IOVs and some PQs, including the packages containing all supporting data that are submitted to the library.
  • Document all deviations (including Protocol Non-Conformance Reports (PNRs) requiring QA approval).
  • Routing documents through PDOCs for review or approval.
  • Attend project meetings as required.
  • Experience with various quality system processes.
 
Job Requirements:  
  • B.Sc. degree or related professional experience within the Biopharmaceutical Industry.
  • 5-7 years previous validation experience required.
  • Developmental experience within a specific area of validation or engineering. Knowledge of current validation/engineering technologies and maintain a solid proficiency of computer skills. 
  • Candidate will be capable of working independently while on assignment, as well interacting with the client in providing responses to project progress and updates on assignment progress. 
  • Knowledge of validation principles, standard concepts, practices, procedures and requirements in GMP regulated environments.
  • Position requires quality and scientific writing skills and capable of working to project timelines.
  • Excellent verbal, written and interpersonal communication skills.
 
Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
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